Jupiter Wellness Submitted a Pre-IND Meeting Request with the US FDA for its Proposed Clinical Program of JW-100 as a Treatment for Mild to Moderate Eczema

Rhea-AI Summary

Jupiter Wellness, Inc. (NASDAQ:JUPW) has submitted a pre-IND meeting request to the FDA for its JW-100 drug, aimed at treating mild to moderate eczema. This meeting aims to gain early FDA feedback on the drug development strategy, potentially accelerating the process. The eczema treatment market is valued at $10 billion and expected to grow at 13% CAGR from 2020-2025. Clinical trials indicate that JW-100 has significantly improved eczema symptoms in 50% of adult patients after two weeks. Jupiter also produces a range of skincare products generating revenue.

Positive

• Submitted pre-IND meeting request, potentially accelerating drug development.
• Clinical trials show JW-100 significantly reduced eczema symptoms in 50% of patients.
• Eczema treatment market valued at $10 billion, indicating high potential revenue.

Negative

• None.

Following receipt of a Pre-Assignment number from the FDA Jupiter Wellness requests Pre-IND meeting

JUPITER, FL / ACCESSWIRE / August 23, 2021 / Jupiter Wellness, Inc. (NASDAQ:JUPW), a developer of enhanced skin care therapeutics and treatments focused on the endocannabinoid system today announced it has submitted a pre-IND (Investigational New Drug) meeting request with the U.S. Food and Drug Administration (FDA) in support of its JW-100 drug development program the treatment of patients with mild to moderate Eczema .

The benefits of holding a pre-IND meeting are to receive early FDA feedback on proposed preclinical and clinical study plans confirming strategy for IND submission. The FDA's statistics show that this can significantly reduce overall development times which impacts time to market.

The Global Eczema (atopical dermatitis) treatment market is valued at $10 billion and expected to grow at a CAGR of 13% from 2020-2025. 31.6 million Americans or roughly 10% of the population suffer from Eczema. 86% are not satisfied with their current treatment.

Through the Company's research and development program, it has shown that in a double-blinded, placebo controlled clinical trial, JW-100 significantly reduced ISGA scores in 50% of adult patients suffering from eczema and JW-100 cleared or reduced eczema following 2 weeks of use.

About Jupiter Wellness
Jupiter Wellness, Inc. (NASDAQ:JUPW) is a leading developer of skin care therapeutics and treatments. The Company's product pipeline of enhanced skin care therapeutics focuses on the endocannabinoid system to address indications including eczema, burns, herpes cold sores, and skin cancer. Jupiter generates revenue from a growing line of proprietary over-the-counter skincare products including its CaniSun™ sunscreen and other wellness brands sold through www.cbdcaring.com.

For additional information, please visit www.JupiterWellness.com. The Company's public filings can be found at www.Sec.gov.

Safe Harbor Statement
To the extent any statements contained in this presentation of Jupiter Wellness, Inc. (the "Company") contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 and the information that are based upon beliefs of, and information currently available to, the company's management as well as estimates and assumptions made by the company's management. These statements can be identified by the fact that they do not relate strictly to historic or current facts. When used in this presentation the words "estimate," "expect," intend," believe," plan," "anticipate," "projected" and other words or the negative of these terms and similar expressions as they relate to the company or the company's management identify forward-looking statements. Such statements reflect the current view of the company with respect to future events and are subject to risks, uncertainties, assumptions and other factors relating to the company's industry, its operations and results of operations and any businesses that may be acquired by the company. Should one or more of these risks or uncertainties materialize, or the underlying assumptions prove incorrect, actual results may differ significantly from those anticipated, believed, estimated, expected, intended, or planned. Although the company believes that the expectations reflected in the forward-looking statements are reasonable, the company cannot guarantee future results, performance, or achievements. Except as required by applicable law, including the security laws of the United States, the company does not intend to update any of the forward-looking statements to conform these statements to actual results.

Investor & Public Relations Contact Info
Phone: 561-244-7100
Email: info@JupiterWellness.com

SOURCE: Jupiter Wellness, Inc.

View source version on accesswire.com:
https://www.accesswire.com/660749/Jupiter-Wellness-Submitted-a-Pre-IND-Meeting-Request-with-the-US-FDA-for-its-Proposed-Clinical-Program-of-JW-100-as-a-Treatment-for-Mild-to-Moderate-Eczema

FAQ

What is the purpose of the pre-IND meeting requested by Jupiter Wellness?

The pre-IND meeting aims to receive early FDA feedback on the JW-100 drug development program for eczema, which can help confirm the strategy for IND submission.

What is the market size for eczema treatments?

The global eczema treatment market is valued at $10 billion and is projected to grow at a CAGR of 13% from 2020 to 2025.

What were the results of the clinical trials for JW-100?

In clinical trials, JW-100 significantly reduced ISGA scores in 50% of adult patients suffering from eczema after two weeks of use.

What is the stock symbol for Jupiter Wellness?

The stock symbol for Jupiter Wellness is JUPW.

When did Jupiter Wellness announce the pre-IND meeting request?

Jupiter Wellness announced the pre-IND meeting request on August 23, 2021.